1. Field of the Disclosure
The disclosure relates in general to techniques to confirm the location of a medical device in a medical patient's body, and more particularly, embodiments of the present disclosure relate to a feeding tube assembly and a light element which is attachable to the feeding tube assembly to identify and confirm that the end of a particular feeding tube that has been inserted into a patient without exposing the patient to radiation.
2. Background Art
Feeding tube intubation is a process involving placement of a soft plastic tube into a patient's stomach or jejunum, otherwise referred to as the small intestine. Typically, the gastric or intestinal feeding tube is inserted through a patient's nose or mouth and travels past the pharynx, down the esophagus and into a patient's stomach or beyond to the small intestine. Intubation is a common medical practice that may assist in the treatment and diagnosis of patients. For example, the intubation of a gastric feeding tube can aid a patient in recovery from surgery or trauma by administering life sustaining nutrition or medications where necessary. Patients who need gastric or intestinal feeding tubes include but are not exclusive to pre-mature neonates, comatose patients, patients requiring mechanical ventilation, chronically ill children, patients requiring face or neck surgeries, cancer patients, and/or post-op surgical nutrition. The feeding tubes are considered temporary, non-surgical, and intended to remain in use for short-term or long-term therapies until a trained physician deems a change medically necessary.
Gastric feeding tube placement is routinely practiced in both medical facilities and in the treatment of in-home-care patients. Intestinal feeding tube placement frequently requires the use of more specialized placement techniques and the placement position is more difficult to confirm in placement. As such, intestinal feeding tube placement is predominantly practiced only in medical facilities.
Feeding tubes are routinely placed in patients using a blind technique, with the operator not knowing the true location of the end of the tube after placement. Accordingly, the end of the feeding tube is commonly misplaced inside of the patient, which may lead to serious problems. For example, where a feeding tube intended for placement in the stomach is not placed deep enough, fluids administered through the feeding tube may seep into the lungs causing problems for the patient. Alternatively, where such a feeding tube is placed too deep, the fluids may be absorbed directly into the intestine, which may not have the appropriate enzymes for processing the fluids, which may also lead to problems. Complications that may result from the improper administration of fluids through an improperly placed feeding tube may include, but are not limited to, pneumothorax, perforated bowel, pneumonia, intestinal distention, aspiration, peritonitis, or placement of the tube into the brain, for example. See, Ellet, Maahs, and Forsee, Prevalence of Feeding Tube Placement Errors and Associated Risk Factors in children, American Journal Maternal Child Nursing, 23:234-39, published 1998; Ellet, What is Known About Methods Of Correctly Placing Gastric Tubes in Adults and Children, Gastroenterology Nursing, 27 (6):253-59, published 2004; Ellet, What is the Prevalence of Feeding Tube Placement Errors and What are the Associated Risk Factors?, The Online Journal of Knowledge Synthesis for Nursing, 4, document 5, published 1997.
The misplacement of feeding tubes in patients happens frequently when blind insertion techniques are used. Research has suggested that blind placement methods of feeding tubes may have a mal-position rate in pediatric and adult patients of up to 40%, moreover more than 20% of the misplaced nasogastric tubes led to pulmonary complications. See Irving, Northington, Kemper Nasogastric Tube Placement and Verification in Children: Review of Current Literature, Nutrition in Clinical Practice, Vol. XX, No. X, published 2014; Metheny and Tiller Assessing Placement of Feeding Tubes, American Journal of Nursing, 101:36-41, published 2001; Metheney and Meert, Monitoring Feeding Tube Placement, Nutrition in Clinical Practice, Vol. 19, no. 5, pp. 487-95, published 2004; Huffman, Karczk, O'Brien, Pieper and Bayne, Methods to Confirm Feeding Tube Placement: Application of Research in Practice, Pediatric Nursing, 30:10-13, published 2004; Westhaus, Methods to Test Feeding Tube Placement in Children, The American Journal of Maternal/Child Nursing, 29:282-87, published 2004; Ellet, How Accurate is Enteral Tube Placement in Children?, MNRS Connection, 14 (1), 14, published 1998. Accordingly, it is often necessary to confirm the location of the feeding tube prior to the administration of any medication or nutrition to avoid problems caused by feeding tube misplacement.
Conventional methods for locating the position of a feeding tube or tubes inside a patient include the use of air insufflation, gastric pH detection methods, gastric enzyme detectors and CO2 detectors. There are problems, however, with the accuracy and reliability of these methods. See Gharpure, Meert, Sarnaik and Metheny, Indicators of Postpyloric Feeding Tube Placement in Children, Critical Care Medicine, 28:2962-66, published 2000; Metheny, Stewart, Smith, Yan, Diebold and Clouse, pH and Concentration of Bilirubin in Feeding Tube Aspirates as Predictors of Tube Placement, Nursing Research 48, 189-97, published 1999; Araujo-Preza, Melhado, Gutierrez, Maniatis and Castellano, Use of Capnometry to Verify Feeding Tube Placement, Critical Care Medicine, 30:2255-2259, published 2002. For example, air insufflation techniques require a user to confirm the location of a tube by listening for a sound of air passing through a feeding tube inside the patient using a stethoscope. Internal noises may lead to a false confirmation of proper placement, for example. Furthermore, feedings and medications may affect the levels of pH, enzyme and CO2 in a patient, thereby affecting the ability of gastric pH, gastric enzymes, and CO2 detectors to produce accurate and reliable results.
Moreover, conventional methods typically require the implementation of equipment that is only available in a hospital or clinical setting and are thus unavailable for use with in-home-care patients. Presently, only air insufflation, the least accurate of the methods, is available to confirm proper placement of feeding tubes for in-home-care patients.
In June 2005, the American Association of Critical-Care Nurses (AACN) issued a practice alert. The alert recommended using an X-ray to visualize a new, blindly inserted gastric tube to ensure that the tube has been properly placed and is in the desired position of the stomach or small intestine before initiating the administration of formula or medications via the tube. See American Association of Critical Care Nurses, Practice Alert-Verification of Feeding Tube Placement, May 2005. Though more accurate than the conventional methods described above, the use of such techniques typically requires at least 5 X-ray scans to confirm the location of the tube, for each time an intestinal feeding tube is inserted blindly at a patients hospital bedside. It is not uncommon for children and neurologically compromised patients to personally remove/extubate the OG or NG tubes more than one time daily which would require additional X-rays for each new tube placement. Such persistent exposure to X-rays throughout a patient's treatment gives rise to serious concern, as the high levels of radiation can have harmful effects on the patient. This concern is especially great where the patient is a child. An additional disadvantage for using X-ray techniques to confirm feeding tube placement is that the equipment necessary to perform the techniques is typically only available in hospital environments and thus of no help to in-home-care patients.
Recently, the use of electromagnetic tube placement devices has provided a means to increase the accuracy of feeding tube placement without the need for X-ray exposure to patients. An example of such a device is the CORTRAK™ system produced by Cardinal Health. The electromagnetic systems involve the placement of an electromagnetic transmitter inside of the feeding tube. As the tube is inserted into the patient, an electromagnetic tracking device tracks the position of the feeding tube, and displays the location on a display unit. Accordingly, operators can respond immediately where a tube placement does not follow the expected path. Because these techniques are only available in medical facilities, they are not helpful when needed for in-home-care.
Once the feeding tube has been inserted into the patient using the aforementioned electromagnetic tracking techniques, the transmitter device must be removed before feedings or medications can be administered through the tube. After the transmitter has been removed, and liquid nutrition started the transmitter must be reinserted into the feeding tube like a rigid stylet to reconfirm the location of the tube. This procedure must allow time lost to stop the administration of feedings to flush the lumen before transmitter reinsertion and adds the risk of tube perforation. Accordingly, once the transmitter has been removed, the position of a feeding tube inside the patient may not be checked. This shortcoming of the electromagnetic system is significant, as patient movement, periodic adjustment of the equipment, peristalsis and other internal functions all contribute to constant shifting and relocation of the feeding tube. Thus, it is necessary to periodically confirm the position of a feeding tube, even after it has been inserted. Without the transmitter located in the tube, the electromagnetic tracking techniques cannot confirm the position after insertion without the use of X-rays.
Thus, the concerns with the present feeding tube placement practices and techniques include several problems relating to accuracy, safety and ease of use for in-home-care patients. Thus a need exists for a method and/or system for detecting, and periodically re-checking, the location of a placed feeding tube in a patient's stomach or small intestine that has the accuracy of X-ray detection without the radiation exposure.